Endit zinc oxide skin protection

Product NDC: 64068-500
Requested package NDC: 64068-500-01
11-digit product format: 640680500
Labeler code: 64068
Product ID: 64068-500_47f5517a-46c6-6d06-e063-6394a90aa5c9
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: EndIt Laboratories, Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-08-09
Substance: ZINC OXIDE
Active strength: 200 mg/g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Endit zinc oxide skin protection
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198911	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e60bb0da-3349-f8f9-e053-2a95a90a9051	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64068-500-01	Endit zinc oxide skin protection	56.7 g in 1 JAR	OINTMENT	56.7	3
64068-500-02	Endit zinc oxide skin protection	113.4 g in 1 JAR	OINTMENT	113.4	3
64068-500-03	Endit zinc oxide skin protection	227 g in 1 JAR	OINTMENT	227	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64068-500	ENDIT ZINC OXIDE SKIN PROTECTION (ZINC OXIDE) OINTMENT [ENDIT LABORATORIES, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20231215_e60bb0da-3349-f8f9-e053-2a95a90a9051.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 54 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Find Your Happy Place	AFTER THE RAIN HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0d27fb-f72f-5e87-e053-2a95a90af7e0	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED CATCUS FLOWER AND BASIL HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba47599c-3e11-cec3-e053-2a95a90aef7b	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	WRAPPED IN YOUR ARMS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0ef938-da18-3b9c-e053-2995a90acb72	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	SUNKISSED OCEAN WAVES HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0db6a3-222a-093f-e053-2a95a90ac88a	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	LAZY WEEKENDS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0f4571-e752-d925-e053-2995a90afd3a	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED GREEN CLAY AND EUCALYPTUS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba48b351-0d7f-5a41-e053-2a95a90a348c	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED COCONUT AND WARM VANILLA HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0ffbf9-7dd0-f685-e053-2995a90a0be0	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED PATCHOULI AND ORANGE FLOWER HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba49e27b-1ade-a75a-e053-2a95a90a1843	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED CHERRY BLOSSOM AND TEA ROSE HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba4979a3-ae30-42e4-e053-2995a90abfe7	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	SWEET TREATS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0fa3cb-8c25-7511-e053-2995a90a4287	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED LAVENDER AND HYSSOP HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba484531-ef7b-17ed-e053-2995a90a50b3	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED GRAPEFRUIT AND RED GINGER HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba4a573d-def4-a735-e053-2995a90a4f29	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER LAVENDER	Conopco Inc. d/b/a/ Unilever	ddcb0871-9903-125f-e053-2a95a90a75de	2024-11-07	Warnings	Exact identifier application number: M016
Dove	MOISTURIZING HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	debc5983-e8bc-c6d5-e053-2995a90af774	2024-11-07	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER FRAGRANCE FREE	Conopco Inc. d/b/a/ Unilever	df734b51-33ae-d6b7-e053-2995a90a08cc	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES SHEA BUTTER AND WARM VANILLA SCENT	Conopco Inc. d/b/a/ Unilever	df73e518-caec-a73b-e053-2995a90a69f5	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER DEEP MOISTURE	Conopco Inc. d/b/a/ Unilever	ddca7c55-0a7e-cea6-e053-2995a90ace5a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	ddcad36b-1909-3bbb-e053-2995a90a295a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	ddcbab1c-7af9-2656-e053-2995a90ad07a	2024-11-07	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER WIPES ALOE AND EUCALYPTUS SCENT	Conopco Inc. d/b/a/ Unilever	df74d901-c86c-ed71-e053-2995a90a39c2	2024-11-07	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	zinc oxide 20 % Topical Ointment	SY	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	zinc oxide 200 MG per GM Topical Ointment	SY	e60bb0da-3349-f8f9-e053-2a95a90a9051	3
198911	ZNO 0.2 MG/MG Topical Ointment	SY	e60bb0da-3349-f8f9-e053-2a95a90a9051	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64068-500-01	64068050001	56.7 g in 1 JAR (64068-500-01)	56.7 g	2022-08-09	0000-00-00	No	No	Current